Performance and Safety of a Novel Ostomy Ring to Improve Ileostomy and Colostomy Management (OstoRing)

NorthShore University HealthSystem

Status: Terminated

Conditions: Stoma Site Leakage

Treatments: Device: OstoRing®

Study type: Interventional

Funder types: Other

Identifiers

NCT04802538

EH19-278

Details and patient eligibility

About

In this study, a novel ostomy ring device will be assessed for safety and efficacy in increasing the lifespan of ostomy pouching equipment.

Full description

In this crossover design trial, patients will be asked to first wear their normal ostomy pouching equipment for 28 days followed by 28 days with the OstoRing®. Patients may choose to continue using the OstoRing for an additional 19 days. Study visits will occur between each section of the trial and will involve a skin assessment and quality of life questionnaires. Additionally, over the course of the trial, participants will be asked to fill out a survey and take a picture of their stoma with ostomy pouching change.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Are at least 18 years of age and have full legal capacity
• Have had an end or loop ileostomy or colostomy for at least 6 months.
• Have used a Hollister 2 piece New Image pouching system for at least 8 weeks
• Able to provide informed consent
• Have a stoma with a diameter of 57mm or less
• Change their pouching system at least two times in seven days

Exclusion criteria

• Unable to give informed consent.
• Are pregnant or currently breastfeeding.
• In the last 2 months has received or is currently receiving, chemotherapy or radiation therapy.
• In the last month has received or is currently receiving systemic or local steroid treatment in the peristomal area.
• Currently suffering from severe peristomal skin problems such as peristomal pyoderma, abscess.
• Currently suffering from a peristomal hernia.
• Known hypersensitivity toward any of the test product (OstoRing® is made of surgical grade stainless steel)
• In the last 30 days has participated or is currently participating in a clinical study
• Assessed with an ostomy skin tool score of ≥3

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Study Group

Experimental group

Description:

All patients will begin the study by using their normal ostomy pouching equipment for 28 days. This will be followed by a transition to using the OstoRing® for 28-47 days.

Treatment:

Device: OstoRing®